Sirdalud ointment instructions for use. Sirdalud - Indications for use, side effects, patient reviews. Application in elderly patients

The medicinal preparation of the Miorolaxing central action is Sirdalud. Instructions for use proposes to take tablets 2 mg and 4 mg, MP 6 mg capsules with painful muscle spasms.

Release form and composition

Sirdalud is produced in the dosage form:

Tablets 2 mg and 4 mg.
Capsules with a modified release of MR 6 mg.

The active ingredient in the composition - tizanidine (in the form of hydrochloride)

pharmachologic effect

The pharmacological action mechanism of the Sirdalud medication, the instruction for use explains this, based on the ability of its active substance, to influence certain receptors, as a result of which the suppression of the neurons of the spinal cord, which are responsible for muscular tone.

As a result of the application, a pronounced minelax effect is provided, allowing to eliminate painful muscle spasms. The drug is an effective means for chronic spasms of spinal and cerebral origin.

It significantly reduces clonic convulsions and spasticity, thereby increasing the amount of active movements and reducing the resistance to passive movements.

Why are Sirdalud appoint?

Indications for the use of Sirdalud medication include:

the painful spasm of skeletal muscles caused by the defeat of the spine (cervical and lumbar syndromes) or arising after operations (about the hernia of the intervertebral disk or the hip armhode);
the consequences of violations of cerebral circulation and children's cerebral paralysis (patients over 18 years old);
the spastic state of skeletal muscles caused by neurological diseases (sclerosis, chronic myelopathy, stroke, degenerative diseases of the spinal cord).

Instructions for use (how to accept)

Sirdalud (tablets or capsules) are prescribed inside. Dosing mode should be selected individually. The reception of the medication should pass with strict adherence to dosages, since the drug has a narrow therapeutic index and high variability of the concentration of teizanidine in the blood plasma.

Initial dose: 2 mg 3 times a day.

With a painful muscular spa: 2 mg or 4 mg (1 tab.) 3 times a day. In severe cases, 2 mg or 4 mg can be additionally taken (preferably before bedtime due to the possible amplification of drowsiness).

In the spasticity of skeletal muscles, due to neurological diseases: 6 mg, divided into 3 receptions. The dose should be raised gradually at 2-4 mg, at intervals from 3 - 4 to 7 days. The therapeutic effect is achieved at a daily dose from 12 to 24 mg, divided into 3 or 4 receptions at equal intervals. Maximum daily dose: 36 mg.

Restrictions in the reception

For people aged 65 years and older, the drug is limited. It is recommended to begin therapy with a minimum dose with a gradual increase to the achievement of the optimal ratio of tolerance and the effectiveness of therapy.

With severe liver disorders, the use of the drug is contraindicated.

With moderately pronounced violations of the liver function, the drug is used with caution. It is recommended to begin treatment with a minimum dose, with a gradual increase before achieving the optimal relaxation ratio and therapy efficiency.

With the termination of the treatment with Sirdalud in order to reduce the risk of developing ricocelization of blood pressure and tachycardia, it should be slowly reduced by a dose to complete abolition of the drug, especially those receiving high doses of the drug for a long time.

Contraindications

severe liver function disorders;

simultaneous reception with ciprofloxacin or fluvoxamine;

hypersensitivity to the main or auxiliary components of the preparation of Sirdalud, from which the tablets can cause side effects;

children's and adolescent age up to 18 years old (due to the limited experience of applying this age category);

pregnancy and lactation period.

Sideflines

weakness;
increased fatigue;
muscle weakness;
reduction of blood pressure;
hallucinations;
insomnia;
bradycardia;
nausea;
gastrointestinal disorders;
drowsiness;
a pronounced decrease in hell up to the collapse and loss of consciousness;
sleep disorders;
dizziness;
dry mouth.

Children, during pregnancy and breastfeeding

Since controlled studies of the use of Tizanidine in pregnant women were not conducted, it should not be applied during pregnancy, except in cases where the potential benefits exceed a possible risk. Sirdalud stands out with breast milk in minor quantities.

Nevertheless, women, nursing children, do not apply the drug. It is not recommended to appoint Sirdalud under the age of 18 years.

special instructions

When developing drowsiness against the background of treatment with the drug, patients should refrain from performing work related to the high concentration of attention and fast psychomotor reaction.

Medicinal interaction

When using the drug, together with cytochrome inhibitors CYP1A2, it is possible to increase the concentration of the teizanidine in the blood plasma. In turn, an increase in the concentration of tizanidine in a plasma can lead to symptoms of overdose by the drug, incl. The elongation of the QTC interval.

The joint use of Sirdalud with CYP1A2 inductors can lead to a decrease in the concentration of the tizaninine in the plasma. The reduced level of tizanidine in plasma can lead to a decrease in the therapeutic effect.

Analogs of medication Sirdalud

The structure determines the analogues:

Tezanidine hydrochloride.
Sirdalud MR.

Vacation conditions and price

The average price of Sirdalud (Tablets 4 MG No. 30) in Moscow is 302 rubles. In Kiev, it is possible to buy a medicine for 365 hryvnia, in Kazakhstan - for 1800 tenge. In Minsk, the pharmacy is offered a drug for 10-11 white. rubles. Released from pharmacies by prescription.

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active substance: Tizanidine;

1 tablet contains 2.288 mg of 4.576 mg of hydrochloride tizanidine, which corresponds to 2 or 4 mg of teizanine, respectively;

excipients : lactose, microcrystalline cellulose, stearin acid, silicon colloidal dioxide.

Dosage form

Pills.

Basic physico-chemical properties:

Sirdalud ® 2 mg - white or almost white color round flat tablets with beveled edges, with notch and inscription "OZ" on one side of the tablet;

Sirdalud ® 4 mg - white or almost white color round flat tablets with beveled edges, with cross-risks on one side and the inscription "RL" on the other side of the tablet.

Pharmacological group

Miorlaxants of the central action. ATH code M03B x02.

Pharmacological properties

Pharmacodynamics.

Tizanidine - relaxant of the skeletal muscles of the central action. Its main place is the spinal cord. Stimulating the presynaptic α-2-adrenal receptors, it suppresses the release of stimulating amino acids, which stimulate the N-methyl-D-aspartate receptors (NMDA receptors). As a result, it is suppressed by polysnaptic signal transmission at the level of inter-line bonds in the spinal cord, which is responsible for excessive muscle tone, and the muscle tone is reduced. Sirdalud ® is effective both with sharp painful muscle spasms and in the chronic spasticity of spinal and cerebral origin. It reduces resistance to passive movements, suppresses spasm and clonic convulsions and improves the strength of active muscle contractions.

Pharmacokinetics.

Suction and distribution.Tizandine is quickly absorbed. The maximum concentrations in the blood plasma is achieved after 1:00 after use. The average bioavailability is 34%. The average distribution volume of the stable state (VSS) after intravenous use is 2.6 l / kg. Binding with plasma proteins is 30%. Relatively low in patients departing pharmacokinetic parameters (with MAX and AUC) facilitates a reliable preliminary estimate of blood plasma levels after oral administration.

Metabolism / output.The drug is subject to fast and extensive metabolism in the liver. Tizandine metabolized in vitro. Mostly CYP1A2. Metabolites are inactive. They are removed mainly by the kidneys (70%). The withdrawal of total radioactivity (that is, substances in unchanged form and metabolites) two-phase, with a quick initial phase (half-life T 1/2 \u003d 2.5 hours) and a slow phase of elimination (T 1/2 \u003d 22 hours). Only a small amount of substance unchanged (about 2.7%) is excreted by the kidneys. The half-life of the substance is unchanged is 2-4 hours.

Pharmacokinetics in individual groups of patients . In patients with renal failure (creatinine clearance less than 25 ml / min), the average value of the maximum plasma concentration is twice as much as this indicator in healthy volunteers, and the final half-life is lengthened to about 14 hours, as a result of which the area under the concentration - time curve ( AUC) grew an average of 6 times.

Research in patients with impaired liver function was not conducted.

Tizandine is metabolized by the CYP1A2 in the liver. In patients with impaired liver function, higher concentrations of substance in blood plasma can occur.

Sirdalud ® is contraindicated in patients with severe liver function disorders.

Pharmacokinetic data on elderly patients are limited.

The floor does not affect the pharmacokinetic properties of the teizanidine.

The effect of ethnic and racial affiliation at the pharmacentics of Tizanidine did not study.

Effect of food . Simultaneous meals do not affect the pharmacokinetic profile of Sirdalud ® tablets. Although the value of the maximum concentration increases by a third, it is not clinically significant. There was no significant impact on suction.

Indications

Painful muscular spasm.
Spastily due to multiple sclerosis.
Spastily due to spinal cord damage.
Spastily due to brain damage.

Contraindications

Increased sensitivity to tizanidine or any auxiliary substances of the drug.
Heavy liver function disorders.
The simultaneous use of tizanidine with powerful CYP1A2 inhibitors, such as fluvoxamine or ciprofloxacin.

Interaction with other medicines and other types of interactions.

The simultaneous use of known CYP1A2 inhibitors can increase the level of tizanidine in the blood plasma.

Increasing the level of tizanidine in blood plasma can lead to the appearance of overdose symptoms, such as the elongation of the Qt interval.

The simultaneous use of the well-known Innductorization CYP1A2 can reduce the level of tizanidine in the blood plasma. Reducing the level of tizanidine in blood plasma can lead to a decrease in the therapeutic effect of Sirdalud ®.

The simultaneous use of powerful CYP1A2 inhibitors, such as fluvoxamine or ciprofloxacin, with teizanidine is contraindicated. The simultaneous use of tizanidine with fluouxamine increases the AUC of Tizaninidine 33 times, while the simultaneous use of tizanidine with ciprofloxacin increases the AUC of teizanidine is 10 times. This can lead to a clinically significant and long-term reduction in atrerial pressure, accompanied by drowsiness, dizziness and reduced psychomotor performance.

The simultaneous use of tizanidine with other CYP1A2 inhibitors, such as antiarrhythmic drugs (amiodarons, mexylene, conpaphenon), cimetidine, some fluoroquinolones (ECCSACIN, PERFLOKSACIN, NORFLOXACIN), ROETEKOXYB, oral contraceptives and tickopyridine is not recommended.

The growth of the levels of tizanidine in the blood plasma can cause symptoms of overdose, including the elongation of the Qt interval.

The simultaneous use of the Preparation of Sirdalud ® with antihypertensive drugs, including diuretics, can sometimes cause arterial hypotension and bradycardia. In some patients who prepared simultaneous treatment with antihypertensive preparations, ricoce arterial hypertension and ricoce tachycardia were observed with a sudden abolition of Tizanidine. In some cases, ricochetic arterial hypertension can cause stroke.

The simultaneous use of the preparation of Sirdalud ® with rifampicin can lead to a 50% reduction in the concentration of the tisanidine. Thus, the therapeutic effect can be reduced by the use of rifampicin during the treatment with the treatment of Sirdalud ®, which can be clinically taking for some patients. Long simultaneous use should be avoided, and if necessary, it should be very careful to adjust the dosage.

The use of the preparation of Sirdalud ® leads to a 30% reduction in the systemic influence of the teizanidine in smokers (more than 10 cigarettes per day). Long-term use of drug chodovikov who smoke a lot requires the appointment of higher doses of the drug.

The simultaneous use of the preparation of Sirdalud ® and other medicines of the central action (for example, sedative and sleeping pills (benzodiazepine or biotrofen), some antihistamine drugs and analgesics, psychotropic drugs, drugs) can enhance the effects of each of the drugs and strengthen the Sirdalud ®'s hypnotic effect. This applies, in particular, simultaneous intake of alcohol, which can unpredictably change or strengthen the Sirdalud ® effect and increase the risk of adverse reactions, so it should be refracted from alcohol consumption,

The purpose of the preparation of Sirdalud ® together with the α-2 adrenoreceptors of agonists (for example with clonidine) should be avoided due to their potential additive hypotensive effect.

Features of application

The simultaneous use of CYP1A2 inhibitors with tizandine is not recommended.

After a sudden cancellation of the drug or a rapid dose reduction in patients, arterial hypertension and tachycardia may occur in patients. In some cases, such ricoce arterial hypertension can cause stroke. Treatment with teizanidine should not be stopped suddenly, but only gradually reducing the dose.

For patients with renal failure (Creatinine clearance

Hepatic insufficiency has been reported related to the use of tizanidine, but patients who received daily doses of up to 12 mg were rarely observed. In this regard, it is recommended to control the liver function 1 time per month during the first four months of therapy in those patients who use tizanidine at a dose of 12 mg or higher and in patients with clinical symptoms indicating liver failure (for example, nausea, loss of appetite or elevated fatigue of unknown etiology). The use of the Preparation of Sirdalud ® should be discontinued if the level of Alt or ACT in the blood serum exceeds the upper limit of the norm 3 times or more for a long period.

Arterial hypotension may occur with the use of tizanidine, as well as the result of drug interaction with CYP1A2 inhibitors and / or antihypertensive drugs. Heavy forms of arterial hypotension were reported, such as loss of consciousness and circulatory collapse.

Care should be taken when using this drug with means, which extend the Qt interval (for example, cisapride, amitriptyline, azithromycin).

Caution is necessary for patients with ischemic heart disease and / or heart failure. ECG controls should be monitored at regular intervals at the beginning of the use of Sirdalud ® drug to such patients.

Before applying this drug, patients with Miashenia gravis must be carefully evaluated by the riskive ratio.

The experience of applying children and adolescents is limited, and therefore the use of the drug Sirdalud ® is not recommended for this category of patients.

Care should be taken when applying this drug to the elderly patients.

Sirdalud ® tablets contain lactose. Patients with rare hereditary diseases - the intolerance to galactose, severe lactase lactase or glucose-galactose syndrome Malabsorption syndrome - Sirdalud ® tablets are not recommended.

Use during pregnancy and lactation

Pregnancy.

Data on the use of Sirdalud ® Pregnant women are limited, so it should not be prescribed during pregnancy, except when the potential benefit for the mother exceeds the possible risk to the fetus.

Breastfeeding.

With the use of tizanidine in rats and rabbits of teratogenic effects were not observed. Animal experiments have shown that Tizandine penetrates breast milk in minor quantities. Therefore, women who are breastfeeding are not necessary.

Fertility.

There was no violation of fertility in the males of rats, obtaining a drug at a dose of 10 mg / kg per day and in females of rats that received the drug at a dose of 3 mg / kg per day. The decrease in fertility was observed in the rats of rats, obtaining a drug in a dose of 30 mg / kg per day and in females of rats that obtained the drug at a dose of 10 mg / kg per day. When using these doses, sedation, weight loss and ataxia were also observed.

The ability to influence the reaction rate when managing motor vehicles or other mechanisms

Tizandine can cause drowsiness, dizziness and / or arterial hypotension, thus weakening the patient's ability to drive a car or work with mechanisms. Risks are increasing while using alcohol.

Therefore, it is necessary to refrain from activities requiring a high concentration of attention and rapid response, for example, from controlling vehicles or working with machines and mechanisms.

Method of application and dose

Syudrude has a narrow therapeutic range and high variable concentration of titsanidine in plasma in different patients. Therefore, it is important to use optimal doses according to the patient's need. Begin treatment follows with a small dose of 2 mg, which makes the risk of side effects from the reception of the drug minimal. If necessary, the dose of the drug is gradually increased in compliance with all necessary precautions. adults

Relief of painful muscle spasms

Apply 2-4 mg 3 times a day. In severe cases, one can take an additional dose of 2 or 4 mg.

Spasticity in neurological violations

The dose should be selected individually for each patient.

The initial daily dose should not exceed 6 mg, divided into 3 receptions. It can be increased gradually up to 2-4 mg two times gradually at intervals of 3-7 days. Usually the optimal therapeutic effect is achieved at a daily dose of 12-24 mg, divided into 3 or 4 receptions. Do not exceed the daily dose of 36 mg.

Special populations of patients

Application for children and teenagers

Experience in the use of the drug Sirdalud ® Children and adolescents are limited, so it is not recommended for the use of children and adolescents.

Application in elderly patients

The experience of using the drug in elderly patients is limited, so caution should be taken when using the preparation of Sirdalud ® this category of patients. It is recommended to begin treatment with a minimum dose and gradually increasing it with "small steps" to achieve the optimal ratio of individual tolerability and therapeutic efficacy of the drug. Patients with impaired kidney function For patients with violations of kidney function (QC Application Patients with impaired Liver function

Treatment of patients with severe liver function disorders is contraindicated. Sirdalud is largely metabolized in the liver. Sirdalud should be used with caution when treating patients with moderately pronounced liver function disorders. Treatment should be started from the dosage itself. It is possible to increase the dose to occur with caution and taking into account individual tolerance by the patient of the preparation of Sirdalud. interruption of treatment

If it is necessary to interrupt treatment, the dose should be reduced slowly and gradually. This is especially true for patients who received an increased dose of the drug for a long time. This reduces the risk of ridichetic increase in blood pressure and tachycardia.

Children

The experience of using the drug in pediatrics is limited. Assign Sirdalud ® Children is not recommended.

Overdose

Very few reports on the overdose of Sirdalud ® were obtained. In all patients who have registered single cases of overdose by this drug, including 1 patient, adopted 400 mg of Sirdalud ®, the recovery has passed without complications.

Symptoms: Nausea, vomiting, arterial hypotension, bradycardia, elongation of Qt interval, dizziness, myiosis, respiratory distress, coma, anxiety, drowsiness.

Treatment: To remove the drug from the body, the multiple use of high doses of activated carbon is recommended.

Forced diuresis may speed up the removal of the drug. Further conduct symptomatic treatment.

Adverse reactions.

Adverse reactions - such as drowsiness, increased fatigue, dizziness, dry mouth, reduced blood pressure, nausea, disorders from the gastrointestinal tract and elevated levels of transaminase serum - are usually poorly expressed and transient in patients using low doses recommended for patients Publishing painful muscular spasm.

When taking doses exceeding recommended for the treatment of spasticity, the above-mentioned adverse reactions occur more often and are more pronounced, but they are rarely so serious to treatment. Such side reactions may also occur: arterial hypotension, bradycardia, muscle weakness, sleep disorder, hallucination and hepatitis.

The emergence of such symptoms was registered after the sudden cancellation of the tizanidine, especially after a long treatment and / or taking of high daily doses and / or accompanying therapy with antihypertensive drugs. Under such circumstances, patients may have arterial hypertension and tachycardia. In some cases, such ricoce arterial hypertension can cause stroke. Therefore, treatment with teizanidine should not be stopped suddenly, but only by a gradual reduction in the dose.

To estimate the frequency of the occurrence of various adverse reactions, the following classification is used: very often (≥ 1/10); Often (≥ 1/100,<1/10); нечасто (≥ 1/1000, <1/100)

rarely (≥ 1/10000,<1/1000); очень редко (<1/10000), включая отдельные сообщения.

Mental disorders: Often - insomnia, sleep disorder; The frequency is unknown - hallucinations.

From the nervous system: Very often - drowsiness, dizziness The frequency is unknown - the confusion of consciousness, vertigo.

From the side of the cardiovascular system: Often - arterial hypotension is infrequent - bradycardia The frequency is unknown - fainting.

From the digestive system: Very often - dry mouth, pain in the gastrointestinal tract, gastrointestinal disorders; Often - nausea.

Hepatobiliary system: Often - elevated levels of transaminase serum frequency unknown - acute hepatitis, liver failure.

On the side of the musculoskeletal system: Very often - muscle weakness.

General violations: Very often - increased fatigue; The frequency of unknown - asthenia, the abolition syndrome, the occurrence of allergic reactions is possible.

From the authorities of the vision: The frequency is unknown - boldness.

Study: Often - reducing the blood pressure pressure, increasing the level of transaminase.

Shelf life

Storage conditions

Store at a temperature not higher than 25 ° C, in an inaccessible place for children.

Packaging

10 tablets in the blister, 3 blisters in the package.

Category of vacation

On prescription.

Manufacturer

Novartis Saglik, Guide, Tarim Uruunleri San. Ve tick. A.S. / Novartis Saglik, Gida Ve Tarim Urunleri San. Ve Tic. As

The location of the manufacturer and its address of the activities of activity

Yenisehir Mah Deadpasis Cad No. 17 (11 Juice # 2), Jacket, Istanbul, TR 34912, Turkey / Yenisehir Mah Dedepasa Cad NO 17 (11 Sok NO. 2) Kurtkoy, İstanbul, TR 34912, Turkey.

Active substance

Tizanidine (Tizanidine)

Release form, composition and packaging

Pills From white to almost white, round, flat, with beveled edges, on one side of the risk and code "OZ".

Auxiliary substances: silicon colloidal dioxide - 0.3 mg, stearic acid - 3 mg, microcrystalline cellulose - 74.412 mg, lactose - 80 mg.

Pills From white to almost white, round, flat, with beveled edges, on one side, crossed risks, to another - code "RL".

Auxiliary substances: Silicon Colloidal dioxide - 0.4 mg, stearic acid - 4 mg, microcrystalline cellulose - 101.024 mg, lactose - 110 mg.

10 pieces. - Blister (3) - Cardboard packs.

pharmachologic effect

Tizandine - Miorlaxant of the central action. The main point of the application of its action is in the spinal cord. Stimulating the presynaptic α 2 -receptors, Tizanidine suppresses the release of exciting amino acids, which stimulate the receptors to N-methyl-D-aspartate (NMDA receptors). As a result, at the level of the intermediate neurons of the spinal cord, a polysinaptic excitation transmission is suppressed. Since this mechanism is responsible for excessive muscular tone, then with its suppression, the muscular tone is reduced. In addition to the Miorolaxing properties of Tizanidin, a moderately pronounced central analgesic effect also provides.

Sirdalud is effective both with an acute painful muscle spa and with chronic spasticity of spinal and cerebral origin. Reduces spasticity and clonic convulsions, as a result of which resistance to passive movements is reduced and the volume of active movements increases.

The musical effect (measurement on the ashworth scale and with the help of the "pendulum" test) and adverse reactions (decrease in heart rate and blood pressure) of the preparation of Sirdalud depend on the concentration of the drug in the blood.

Pharmacokinetics

Suction

Tizandine is absorbed quickly and almost completely. C max in plasma is achieved about 1 hour after receiving the drug. Due to pronounced metabolism with the "first passage" through the liver, the average bioavailability value is about 34%.

The Mach of Tezanidine is 12.3 ng / ml and 15.6 ng / ml after one-time and multiple tease of tizanidine at a dose of 4 mg, respectively.

The simultaneous meal does not affect the pharmacokinetics of the Tizanidine (with the use of 4 mg in the form of tablets or 12 mg in the form of a capsules with a modified release).

Simultaneous meals do not affect the pharmacokinetics of the Tizanidine (when using the preparation in the form of tablets 4 mg). Despite the fact that the value of C MAX increases by 1/3 when taking after meals, it is not clinically significant. There is no significant effect on suction (AUC). Tizandine in the dose range from 1 mg to 20 mg is characterized by linear pharmacokinetics.

Distribution

The average V D in the equilibrium state at C / in the introduction is 2.6 l / kg. Binding with plasma proteins is 30%.

Metabolism

Tizandine quickly and largely (about 95%) is metabolized in the liver. In vitro Tizanidine is mainly metabolized by the CYP1A2 isoenzyme. Metabolites are inactive.

Election

The average T 1/2 of the teizanidine from the systemic blood flow is 2-4 hours. It is removed mainly by the kidneys (approximately 70% dose) in the form of metabolites; The share of unchanged substance accounts for about 4.5%.

Pharmacokinetics in special clinical cases

W. patients with impaired kidney function (KK≤ 25 ml / min) C Max Tizanidine in a blood plasma is 2 times higher than in healthy volunteers, the final T 1/2 reaches 14 hours, which leads to an increased (about 6 times) of the systemic bioavailability of the teizanidine (measured by AUC ).

Specific studies of U. patients with impaired liver function Not conducted. Since tizanidine is mainly metabolized in the liver of CYP1A2 with the liver, violation of the liver function can lead to an increase in the systematic effects of the drug.

Pharmacokinetics data patients older than 65 years Limited.

Floor Does not affect the pharmacokinetic properties of Tizanidine.

Influence ethnic and racial The pharmacokinetics of Tizanidine has not been studied.

Indications

Painful muscular spasm:

associated with static and functional diseases of the spine (cervical and lumbar syndromes);
after surgical interventions (for example, about the hernia of the intervertebral disk or osteoarthrosis of the hip joint).

Spasty of skeletal muscles in neurological diseases, including:

with multiple sclerosis, chronic myelopathy, degenerative diseases of the spinal cord;
under the consequences of brain circulation disorders;
with the consequences of children's cerebral paralysis (patients over 18 years old).

Contraindications

increased sensitivity to tizandine or to any other component of the drug;
violation of the liver function of severe;
simultaneous use with strong CYP1A2 isoenzyme inhibitors, such as fluvoxamine or;
it is not recommended to apply in patients with rare hereditary diseases such as lactase deficiency, lactose intolerance, glucose-galactose macabsorption, because Dosage form contains lactose.
patients under 18 years old (since experience in the use of the drug in this category of patients is limited).

FROM caution It is recommended to use the drug in patients over 65 years old, patients with impaired kidney function, patients with impaired liver function of medium severity; Simultaneously with drugs extending the Qt interval (for example, cisaprid, azithromycin).

Dosage

Sirdalud has a narrow therapeutic index and high variability of the concentration of tizanidine in the blood plasma of patients, so careful selection of the dose is necessary.

Dose and dosing mode should be selected individually depending on the patient's needs. The use of the preparation in the initial dose of 2 mg 3 times / day reduces the risk of developing side effects.

The drug is taken inward. Tablets 2 mg and 4 mg can be divided into two equal parts.

For painful muscular spasmeSirdalud is usually used at a dose of 2 mg or 4 mg 3 times / day. In severe cases, 2 mg or 4 mg can be additionally taken (preferably before bedtime due to the possible amplification of drowsiness).

For spasty of skeletal muscles caused by neurological diseases The initial daily dose should not exceed 6 mg, divided into 3 receptions. The dose should be raised gradually by 2-4 mg, at intervals from 3-4 to 7 days. As a rule, the optimal therapeutic effect is achieved at a daily dose of 12 to 24 mg, divided into 3 or 4 receptions at equal intervals. Do not exceed a dose of 36 mg / day.

Experience in the use of the drug Sirdalud patients aged 65 years and older

Treatment patients with renal failure (QC less than 25 ml / min) It is recommended to start with a dose of 2 mg 1 time / day. The increase in dose is carried out by small "steps", taking into account portability and efficiency. If it is necessary to achieve a more pronounced effect, it is recommended to first increase the dose used 1 time / day, after that increase the multiplicity of use.

patients with severe liver disorderscontraindicated. W. patients with violation of the liver function of the mediumthe drug should be used with caution; It is recommended to begin therapy with a minimum dose, with a gradual increase to the achievement of the optimal relaxation ratio and therapy efficiency. Recommendations for controlling the liver function indicators are listed in the section "Special Instructions".

Interruption of treatment

With the termination of therapy with the drug of Sirdalud in order to reduce the risk of developing ricocertic arterial hypertension and tachycardia, it should be slowly reduced by a dose until complete cancellation of the drug, especially in patients receiving high doses of the drug for a long time.

Side effects

When taking the drug in small doses recommended for the relief of the painful muscle spasm, drowsiness, increased fatigue, dizziness, dry mouth, decreased blood pressure, nausea, gastrointestinal disorders, increase the activity of hepatic transaminases. Usually the above-described adverse reactions are moderately expressed and transient.

When receiving in higher doses recommended for the treatment of spasticity, the above-mentioned unwanted reactions (HP) occur more often and are more pronounced, but they are rarely so heavy to be able to cancel the drug. In addition, the following phenomena may occur: bradycardia, muscle weakness, insomnia, sleep disorders, hallucinations, hepatitis.

Hp is grouped in accordance with the classification of organs and systems of the MEDDRA organs, within each group are listed in order to reduce the frequency of occurrence. Definition of categories of HP frequency: Very often (≥1 / 10); Often (≥1 / 100,<1/10); нечасто (≥1/1000, <1/100); редко (≥1/10 000, <1/1000); очень редко (<1/10 000), включая отдельные сообщения.

From the nervous system: Very often - drowsiness, dizziness.

From the psyche: Often - insomnia, sleep disorders.

From the side of the cardiovascular system: Often - decreased blood pressure (in some cases expressed, up to the collapse and loss of consciousness); Infrequently - bradycardia.

From the digestive system: Very often - gastrointestinal disorders, dry mouth; Often - nausea.

On the side of the musculoskeletal system: Very often - muscle weakness.

General disorders:very often - increased fatigue.

Laboratory Indicators: Often - increasing the activity of hepatic transaminases.

With a sharp abolition of the preparation of Sirdalud after prolonged treatment and / or taking high doses of the drug (and after simultaneous use together with hypotensive drugs), the development of tachycardia was noted and an increase in blood pressure, capable of leading to acute violation of cerebral circulation, so the dose of Sirdalud's drug should be reduced Gradually, until complete cancellation of the drug.

Selected reports of HP according to the application in clinical practice

Since in the post-registration period, the HP report is voluntary from the population of an indefinite size, it is not possible to reliably assess the frequency of their occurrence. frequency unknown).

From the immune system: Hypersensitivity reactions, including anaphylactic reactions, angioedema edema and urticule.

From the psyche: hallucinations, confusion of consciousness.

From the nervous system: dizziness.

From the body of the vision: Bulk view.

From the side of the liver and biliary tract: Hepatitis, liver failure.

From the side of the skin and subcutaneous fabrics: Skin rash, erythema, skin itching, dermatitis.

General disorders: Asthenium, cancellation syndrome.

If any of the side effects specified in the instructions are aggravated, or the patient noticed any other side effects not listed in the instructions, he must inform the doctor about it.

Overdose

To date, several reports were obtained to overdose the preparation of Sirdalud, including the case when the dose adopted was 400 mg. In all cases, recovery has passed without features.

Symptoms:nausea, vomiting, decreased blood pressure, lengthening the Qt C, dizziness, drowsiness, mios, anxiety, inhibition of breathing, coma.

Treatment:to remove the tizanidine from the body, a multiple receiving of activated carbon is recommended. Forced diuresis also, perhaps, will accelerate the removal of the drug of Sirdalud. In the future, symptomatic treatment is carried out.

Medicinal interaction

With the simultaneous use of Sirdalud preparation with cytochrome inhibitors CYP1A2, it is possible to increase the concentration of tizanidine in the blood plasma. In turn, an increase in the concentration of tizanidine in a plasma can lead to symptoms of overdose by the drug, incl. The elongation of the interval Qt c.

The simultaneous use of the CYP1A2 inductors can lead to a decrease in the concentration of tizanidine in plasma. The reduced level of tizanidine in plasma can lead to a decrease in the therapeutic effect of the preparation of Sirdalud.

Contraindicated combinations of the drug Sirdalud

The simultaneous use of teizanidine with fluouxamine or ciprofloxacin, which are CYP1A2 cytochrome inhibitors, contraindicated.

When the preparation of Sirdalud with fluoroxamine or ciprofloxacin is noted, respectively, a 33-fold and 10-fold increase in Tizanidine AUC. The result of combined use may be a clinically significant and long-term decrease in blood pressure, accompanied by drowsiness, dizziness, reducing the velocity of psychomotor reactions (in some cases up to the collapse and loss of consciousness).

It is not recommended to assign Tizanidine together with other inhibitors of CYP1A2 isoenzyme - antiarrhythmic drugs (, mexylene, conpaphenon), cimetidine, some fluoroquinolones (ECCSACIN, PERFLOXACIN, NORFLOXACIN), ROETEKOXIBU, oral contraceptives, tylopidine.

Combinations of the Preparation of Sirdalud, requiring adherence

Care must be taken when the preparation of Sirdalud with preparations lengthening the Qt interval (for example, cisapride, amitriptyline, azithromycin).

Hypotensive drugs

The simultaneous purpose of the preparation of sirdalud with hypotensive drugs, including diuretic, can sometimes cause a pronounced decline in blood pressure (in some cases up to the collapse and loss of consciousness) and bradycardia.

With a sharp cancellation of the preparation of Sirdalud after use, together with hypotensive drugs, the development of tachycardia was noted and an increase in blood pressure, which in some cases could lead to an acute violation of the cerebral circulation.

Rifampicin

The simultaneous reception of the preparation of sirdalud and rifampicin leads to a 50% reduction in the concentration of the tizaninine in the blood plasma. As a result, the therapeutic effect of the preparation of Sirdalud may decrease that it may have clinical significance for some patients. Long joint use of rifampicin and tizanidine should be avoided, with the impossibility of it is recommended a thorough selection of the dose of teizanidine (increase).

Other medicines

Sedative, sleeping pills (benzodiazepine, ballopen) and other drugs, such as antihistiminity drugs, can also increase the sedative effect of tizanidine.

The preparation of the preparation of sirdalud with other α 2-adrenoreceptor agonists (for example, clonidine) should be avoided due to the potential enhancement of the hypotensive effect.

Smoking

The systemic bioavailability of the preparation of Sirdalud in smokers (more than 10 cigarettes per day) is reduced by about 30%. Long-term therapy by the preparation of sirdalud smokers can require higher doses than the average therapeutic.

Alcohol

During therapy, the preparation of Sirdalud should be avoided by alcohol, because It can increase the likelihood of unwanted phenomena (for example, decline in blood pressure and inhibition). Sirdalud can enhance the overwhelming effect of ethanol on the CNS.

special instructions

Arterial hypotension may arise against the background of the use of the preparation of Sirdalud, as well as as a result of drug interaction with CYP1A2 inhibitors and / or. A pronounced decrease in blood pressure can lead to loss of consciousness and collapse.

There have been reported on cases of violations of the liver function associated with teizanidine, however, when applying a daily dose to 12 mg, these cases were rare. In this regard, it is recommended to control the functional hepatic samples 1 time per month in the first 4 months of treatment in those patients who are appointed by Tizanidine in a daily dose of 12 mg and above, as well as in cases where clinical signs are observed, which suggest impaired liver function, - such as inexplicable nausea, anorexia, feeling of fatigue. In the case when the activity of ALT and AST in serum is experimental than VGN 3 times or more, the use of the Sirdalud preparation should be discontinued.

Impact on the ability to control vehicles and mechanisms

Patients who, against the background of the use of the drug, there are drowsiness, should be recommended to refrain from activities requiring a high concentration of attention and rapid response, such as driving vehicles or working with machines and mechanisms.

Pregnancy and lactation

Since controlled studies of the use of Tizanidine in pregnant women were not conducted, it should not be applied during pregnancy, except in cases where the potential benefits exceed a possible risk.

In animal studies, the phenomena of teratogenicity was revealed. When applying in doses of 10 and 30 mg / kg / day in animals, an increase in the period of gestation is noted, cases of prenatal and postnatal fetus loss are recorded, as well as a delay in the development of the fetus. When applying the above doses, the females have noted pronounced signs of miolaxation and sedative action. Based on the body surface area, the specified doses exceeded the maximum recommended dose for humans (0.72 mg / kg / day) at 2.2 and 6.7 times.

In studies in animal, Tizandine has highlighted in small quantities with milk in lactating females. Sirdalud should not be used during lactation (breastfeeding), because There is no data on the penetration of tizanidine into breast milk in humans.

Contraception.Patients with preserved reproductive potential should be informed about the unfavorable effect of the drug on the developing fruit revealed in research in animals. During the use of the drug, as well as for 1 day after the cessation of drug intake, patients with preserved reproductive potential should use reliable ways of contraception (with the right and long use of which the frequency of pregnancy is<1%).

Pregnancy test.Before the use of the preparation of Sirdalud in patients with preserved reproductive potential, it is recommended to obtain a result of a pregnancy test.

Influence on fertility.In the studies in animals, there was no adverse effect on fertility in individuals and female individuals when using Tizanidine in a dose of 10 mg / kg / day. It was noted a decrease in fertility in male individuals receiving tisanidine in a dose, exceeding 30 mg / kg / day, and in female individuals - in a dose that exceeds 10 mg / kg / day. Based on the body surface area, the specified doses exceeded the maximum recommended dose for humans (0.72 mg / kg / day) at 2.2 and 6.7 times. When applying these doses from the mother, behavioral effects and clinical signs were noted, including a pronounced sedative effect, a decrease in body weight and ataxia.

Childcare

The experience of using the drug in patients under 18 is limited. The use of the preparation of Sirdalud in this category of patients is not recommended.

With violations of the kidney function

Treatment patients with renal failure (QC less than 25 ml / min) It is recommended to start with a dose of 2 mg 1 time / day. The increase in dose is carried out by small "steps", taking into account portability and efficiency. If you need to get a more pronounced effect, it is recommended to first increase the dose of 1 time / day, after which the multiplicity of destination increases.

When violations of the liver function

Application of the drug Sirdalud patients with severe liver function disorders contraindicated. W. patients with moderately pronounced liver function The drug should be used with caution; It is recommended to begin therapy with a minimum dose, with a gradual increase to the achievement of the optimal relaxation ratio and therapy efficiency.

Application in old age

Experience in the use of Sirdaluda patients aged 65 years and olderlimited. It is recommended to begin therapy with a minimum dose with a gradual increase to the achievement of the optimal ratio of tolerance and the effectiveness of therapy.

Conditions of vacation from pharmacies

The drug is released by the prescription.

Terms and Storage Terms

The drug should be stored in an inaccessible place at temperatures not higher than 25 ° C. Shelf life - 5 years.

In the article, consider what Sirdalud tablets.

The drug can influence the tone of skeletal muscles, showing moderate painkillers. This drug is attributed to the group of mines. Its active component is quite famous in pharmacology substance Tizanidine.

About preparation

Do not everyone know, from which Sirdalud tablets help. This drug affects a skeletal muscles, against the background of its application, a moderate painkiller effect is manifested. The scope of application of this tool is considered to be the presence of a spastic violation of cerebral and spinal genesis. A failure can be expressed in chronic and in acute form.

The preparation of Sirdalud decreases the manifestation of spasms and clonic convulsions. The active substance as part of oral administration is absorbed quickly and almost completely. The maximum plasma concentration is noted, as a rule, an hour after the use of the drug. The medication is displayed along with the urine. Meals at the same time with pills do not affect the pharmacokinetic process and on absorption. Now let's talk about the pharmacological properties of the presented medical device, as well as below, consider the testimony of Sirdalud.

Pharmacological effects of medication

The Tizanidine substance is primarily a minelaxant for central exposure. The basic point of the application of its influence is directly in the spinal cord. This medicine stimulates the presynaptic receptors, suppressing the release of exciting amino acid, which stimulates methyl and aspartate. As a result, the effect in the body is suppressed by the suppression of polysinaptic excitation transmission at the neuron level of the spinal cord. Since it is this mechanism in response for a muscular excess tone, then on the background of its suppression decreases. In addition to the Mioroxizing property of Tyzandine, a moderately manifesting analgesic central effect can also be additionally provided.

It is worth noting that the preparation "Sirdalud" is very effective in sharp painful muscle spasms, exactly, as in the chronic spasticity of cerebral and spinal genes. This drug decreases the manifestation of clonic convulsions, as a result of which resistance to passive movement decreases and the amount of active actions increases. The mineral effect along with the adverse reactions of drugs directly depend on the concentration of the drug in the patient's blood plasma. Next, we find out what kind of doctors usually prescribe this medicine drug to your patients.

What is the Tablet "Sirdalud"?

Tell in more detail in this matter. Indications to its use are:

The presence of a patient with spasticity of skeletal muscles caused by a neurological impairment. This may be cerebral paralysis along with degenerative pathologies of the spinal cord, multiple sclerosis, problem cerebral circulation, myelopathy, and so on. Indications for the use of Sirdalud tablets must be strictly observed.
The occurrence of functional diseases of the spinal column.
In the framework of the postoperative period for recovery after surgery, for example, after the operation to eliminate the intervertebral hernia.

Indications for the use of medication "Sirdalud" are described in the instructions.

Nuances of use in neurological diseases

The medicine is allowed to be used in the conditions of excessive excitability of the nervous system in order to eliminate spasms with convulsions and convulsions of the limbs. The drug can also be used to combat the advent of nerve cough and diaphragm spasms. The transfer of excitation by means of nervous cells is blocked at the level of the nervous system, which is due to the intermediate spinal neurons. The effect in this case comes fast enough. The pathology of the spinal and cerebral genesis in various forms of its manifestation is also treatable by this medicine.

It is worth noting that this medication has a high biological accessibility. For example, the maximum concentration in the human body comes, as a rule, thirty minutes after using a tablet. The medicine is removed from the body of the kidney over one day, therefore it is used with great care in the presence of nephrological diseases.

It is necessary to draw attention to the fact that it is strictly forbidden to use this medical drug under therapy with the means of which include a substance called Fluvoxamine. When the patient needs a very quick effect from the use of this product, it is best to use not a form of tablets, but a suspension intended for intramuscular and intravenous administration.

For which Sirdalud is prescribed, you can clarify the doctor.

What is justified by the use of medication?

The main active substance of these pills, as already reported, is Tizandine. This active ingredient contributes to the process of the minelaxation of the spinal cord, making it without any visible consequences for the human nervous system. It is because of this that it is possible to achieve relaxation of skeletal smooth muscles and eliminate seizures with spasms.

How to take "Sirdalud"?

Instructions for using tablets

In spasms of skeletal muscles arising from neurological pathology, the dosage is selected depending on the patient's reaction to the drug, and, in addition, from the severity of general symptoms:

It is worth emphasizing that the initial dosage of this medicine is three times 2 mg "Sirdaluda".
A few days later, you can increase dosing and take 3 or even 6 milligrams.
The optimal daily rate is from 12 to 24 milligrams.
Dosages above 36 milligrams per day are fraught with the development of side effects in a patient.

It is also necessary to mention the dosage for patients in old age. This person is always adjusted for this category. Such patients should be under regular control of medical personnel. Often the dose is reduced, because the elderly patients have been slowed down the kidney clearance (we are talking about the speed of the renal excretion of different substances from the blood). Large quantities of drugs can cause accumulation of metabolites in the blood along with the development of overdose and the appearance of all sorts of adverse reactions.

There are also nuances on the reception of this medication and in shortness of the kidneys. Thus, at the same time, the middle rate of the drug is usually three times in 2 mg of Sirdalud. Depending on the subsequent clinical picture and from the overall portability of a particular patient of this drug, the dosing with multiplicity of reception is adjusted.

Side effects

When using the therapeutically justified dose of SirdalUD according to the instructions for use, adverse reactions are almost never developing in patients. It is extremely rarely given nausea with digestion disorders. A slightly more often manifests hypotension in combination with drowsiness, weakness, dry mouth and the like.

When prescribing an increased amount of the drug (for removing strong spasms), side effects may occur much more often, but this is not considered a reason to cancel the medicine. In such cases, there are often side effects in the form of hypotension and bradycardia, the insomnia is less likely to be registered in combination with weakness and sleep disorders. Very rarely, hepatitis is possible in patients.

Contraindications

This medical drug is categorically prohibited to be taken against the background of severe disorders of hepatic and renal functions. In addition, the presented medical agent is not suitable for treatment in a number of following situations:

Against the background of the superdexcation of the body of the patient on Tizandine.
With a combination of tizanidine with a medicine "Fluvoxamine".

It is worth noting that some time ago, special studies on animals were carried out, which did not prove the presence of the teratogenic effects of this drug on the fruit. However, pregnant women were not conducted on the action of this medicine. Thus, doctors still do not recommend assigning this medication during the fetus period. In addition, it is necessary to take into account that the medication in question falls into breast milk, in connection with this, for nursing women, this medicine is also not recommended for the appointment.

Is it still helping Sirdalud pills?

With osteochondrosis

Back pains are a factor in lowering the quality of life. As a rule, such people occur due to pathologies that develop in the spinal column. One of the main factors for the occurrence of pain in the area is osteochondrosis. Against the background of this disease, people occur degenerative and dystrophic changes in the spine.

To eliminate pain in the presence of osteochondrosis that are associated with an increase in muscle tone, Miorlaxant "Sirdalud" is used in the amount of 2 or 4 milligrams several times a day. The mechanism of the effects of this drug may differ significantly from the pharmacological influence of other muscle relaxants. The drug is used when the remaining means lowering the muscle tone do not provide patients due effect. The great advantage of the drug under consideration is primarily in the fact that when the muscle tone is reduced, it does not affect their strength.

Children

The appointment of a medical device "Sirdalud" Children is usually not recommended strictly. Clinical studies on the safety of drug use in this age group, unfortunately, were not conducted.

Preparations "Sirdalud" and "Middokalm"

The medical drug called "Middokalm" appeared on the pharmaceutical market in Russia much earlier than the "Sirdalud" means. Both of these medicines are analogues, but have absolutely different active ingredients. The impact of "Middokalm" today is much better studied. It is similar to Miorolaxanta has an extensive range of applications. But the drug "Sirdalud" but in the therapeutic doses causes many fewer side reactions in patients.

Is it worth applying with alcohol?

The use of the presented medical preparation in combination with alcohol is extremely undesirable for all patients. The fact is that alcohol is enhanced by the sedative and sleeping rendering of Sirdalud.

Medication interaction

As for the interaction, once again it is necessary to emphasize that this medicine cannot be combined with the drug "Fluvoksamin". In addition, it is sufficiently greater caution in the framework of the combination of the drug under consideration with such means as "Mexylene", Amiodaron, Propapanen, Pofloxacin, Norfloxacin, "Econxacin", "Cimetidine", "Tiklopidine", " Ciprofloxacin "," Ropekoxib ", as well as with hormonal oral contraceptives. In combination with diuretics or with hypotensive drugs, this drug is able to cause bradycardia, reinforcing the arterial hypotension.

Overdose

An overdose phenomenon with this medical drug has repeatedly met in clinical practice. At the same time, the symptoms of an overdose appears to break the breath along with vomiting, drowsiness, hypotension, anxiety, miosis, dizziness, and the like. With therapy of the manifestations of overdose in particular, the effective means is considered forced diuresis.

Composition and format of the release of medication: tablets of 2 and 4 milligrams

Dosage "Sirdaluda" 2mg and 4 mg, in a blister, as a rule, contains thirty tablets. The active substance, as already mentioned, is the special component of Tizandine. Additional substances are microcrystalline cellulose, along with stearic acid, anhydrous lactose, colloidal silicon dioxide, and so on.

additional information

In clinical practice, cases of hepatic impaired disorders were repeatedly described, which were directly related to the use of this preparation. Therefore, during therapy, it is recommended to periodically monitor control of hepatic indicators. In the event that during treatment in patients there are symptoms in the form of the loss of appetite and unfortunate nausea, then the analysis of the functioning of the liver is carried out much more often. The fact is that such signs sometimes indicate a significant deterioration in hepatic work. When the patient begins to celebrate drowsiness at the background of taking this medicine, hence he should certainly refrain from driving transport.

Of course, it is indicated in the instructions for use, from which the Tablets "Sirdalud" help. But there are no information about the analogues and cost.

Analogs and price

This medicine, like others, has its analogues, which can be used if this drug is for some certain reasons for treatment cannot use. So, the analogues of the considered means include "Tizanidine" along with "Tizanil", "Tizalud" and so on. The cost of Sirdalud tablets for thirty pieces in the package approximately about five hundred rubles. Now consider the reviews of the patients and find out what they think and write in their comments on the use of this medication within the framework of treatment.

Sirdalud (active ingredient - Tizanidine) is a central action minelaxant with a point of application of action in the alpha receptors of the spinal cord.

As a result of the influence on receptors, a decrease in the production of amino acids incentive transmission of the nerve impulse is reduced, precisely because of this, the final effect of the drug occurs - blocking at the level of intermediate neurons of the exciting pulse. There is a slight painkillers.

The active substance during oral administration is absorbed quickly and almost completely. The maximum concentration of teesanidine in the plasma is observed in an hour after receiving the drug.

Clinical and Pharmacological Group

Miorosant central action.

Terms of sale from pharmacies

You can buy a doctor's prescription.

Price

How much is Sirdalud in pharmacies? The average price is at the level of 250 rubles.

Composition and form of release

Drug form Sirdalud - Tablets: from almost white to white, round, flat, with beveled edges of the form, 2 mg - on one side of the code "OZ" and the critical risk; 4 mg - on one side of the "RL" code, to another crossed risks (in blisters of 10 pcs., 3 blisters in a cardboard pack).

1 tablet composition:

active substance: Tizanidine - 2 or 4 mg (in the form of tizanidine hydrochloride - 2,288 or 4,576 mg);
additional components: anhydrous colloidal silicon dioxide - 0.3 / 0.4 mg, microcrystalline cellulose - 74,412 / 101.024 mg, stearic acid - 3/4 mg, lactose monohydrate - 80/10 mg.

pharmachologic effect

Sirdalud refers to the central action minelaxants. It affects certain areas of the spinal cord by stimulating the presynaptic alpha 2 -receptors, which leads to the braking of exciting amino acids that activate receptors to N-methyl-D-aspartate (NMDA receptors). This causes the inhibition of polysinaptic excitation transmission at the level of intermediate neurons localized in the spinal cord. Since excessive muscular tone is provoked precisely by such a mechanism, with its suppression there is a decrease in muscle tone. In addition to the miorlaxing properties, Tizandine is also characterized by the central analgesic effect of moderate severity.

The effectiveness of Sirdaluda both in chronic spasms of cerebral and spinal genes and with a muscular spa, accompanied by sharp painful sensations, has been proven. The drug reduces the risk of developing clonic convulsions and reduces spasticity, which causes a decrease in resistance to passive movements and an increase in the volume of active movements. The musical effect, measured by means of the "pendulum" test and on the Ashworth scale, and side effects (reduction of blood pressure and heart rate) are determined by the content of tizanidine in the blood plasma.

Indications for use

The instructions for use of the drug is indicated for the following readings for its use:

cervical and lumbar syndromes;
muscle painful spasms caused by diseases of the spine;
pain after surgical interventions, neurological pathologies, the hernia of the intervertebral disk, osteoarthrosis, treatment;
spasty of skeletal muscles with neuralgia, sclerosis, chronic myelopathy, children's cerebral paralysis, degenerative diseases of the spinal cord, the consequences of the violation of the cerebral circulation.

Contraindications

Absolute:

age up to 18 years (safety and efficacy for this group of patients has not been studied);
the lactation period (safety and efficiency for this group of patients has not been studied);
individual intolerance to the components of the drug;
severe disorders of the liver functions;
combined use with strong cytochrome P450 1A2 (CYP1A2), such as ciprofloxacin or fluvoxamine;
rare hereditary intolerance to galactose, severe lactase insufficiency or malabsorption of galactose / glucose (the preparation includes lactose).

Caution is required when the sirdalud is prescribed in the presence of the following diseases / states (relative contraindications):

age from 65 years;
pregnancy (safety and efficacy for this group of patients has not been studied; the use of Sirdalud is possible if the expected effect is higher than possible harm);
functional disorders of the kidneys;
moderate disorders of the liver functions.

Appointment during pregnancy and lactation

Studies on animals were conducted, which did not prove the presence of teratogenic effects of the drug. However, pregnant women have controlled studies of the drug have not been conducted. Therefore, it is still recommended not to appoint Sirdalud during pregnancy.

The drug enters breast milk, so for nursing women the drug is also not recommended for its intended purpose.

Dosage and method of application

As indicated in the instructions for the use of Sirdalud, it has a narrow therapeutic index and high variability of the concentration of tizanidine in the blood plasma of patients, so careful selection of the dose is necessary.

Dose and dosing mode should be selected individually depending on the patient's needs. The use of the preparation in the initial dose of 2 mg 3 times / day reduces the risk of developing side effects.

The drug is taken inward. Tablets 2 mg and 4 mg can be divided into two equal parts.

With a painful muscular spa Sirdalud, as a rule, applied at a dose of 2 mg or 4 mg 3 times / day. In severe cases, 2 mg or 4 mg can be additionally taken (preferably before bedtime due to the possible amplification of drowsiness).
In spasticity of skeletal muscles, due to neurological diseases, the initial daily dose should not exceed 6 mg, divided into 3 receptions. The dose should be raised gradually by 2-4 mg, at intervals from 3-4 to 7 days. As a rule, the optimal therapeutic effect is achieved at a daily dose of 12 to 24 mg, divided into 3 or 4 receptions at equal intervals. Do not exceed a dose of 36 mg / day.
The experience of using the preparation of Sirdalud in patients aged 65 years and older is limited. It is recommended to begin therapy with a minimum dose with a gradual increase to the achievement of the optimal ratio of tolerance and the effectiveness of therapy.
Treatment of patients with renal failure (QC less than 25 ml / min) It is recommended to start with a dose of 2 mg 1 time / day. The increase in dose is carried out by small "steps", taking into account portability and efficiency. If it is necessary to achieve a more pronounced effect, it is recommended to first increase the dose used 1 time / day, after that increase the multiplicity of use.

The use of the preparation of Sirdalud in patients with impaired liver function of severely contraindicated. In patients with impaired liver function of the medium, the drug should be used with caution; It is recommended to begin therapy with a minimum dose, with a gradual increase to the achievement of the optimal relaxation ratio and therapy efficiency. Recommendations for controlling the liver function indicators are listed in the section "Special Instructions".

Interruption of treatment

Side effect

When using Sirdalud in small doses (with a painful muscular spa), the side effects listed below are expressed moderately and pass on their own. The reception of higher doses of the drug recommended during spasticity leads to increased cases of occurrence and improving the severity of adverse reactions, however, truly severe cases requiring the cancellation of the drug, rarely occur.

Muscular system: Very often - Miastic;
Laboratory indicators: often - increase the activity of liver enzymes;
Digestive system: Very often - gastrointestinal disorders, dryness sensation in the oral cavity; often - nausea;
Nervous system and psyche: Very often - dizziness, drowsiness; Often - sleep disorders, insomnia;
Cardiovascular system: often - decrease in blood pressure (in some cases, expressed, up to the loss of consciousness and collapse); infrequently - bradycardia;
Other reactions: Very often - increased fatigue.

In clinical practice, unwanted side effects were noted on the part of the following systems and organs (the frequency of their occurrence is not established):

Liver and biliary ways: liver failure, hepatitis;
Nervous system, psyche and organs of feelings: Vertigo, confusion of consciousness, tumping vision, hallucinations;
Other reactions: cancellation syndrome, asthenia.

Overdose

All known cases of overdose ended with recovery. If the dose is exceeded, the patient may feel nausea, drowsiness, anxiety, dizziness. Feeding severe consequences will help the reception of sorbents, in particular activated carbon.

special instructions

Arterial hypotension may arise against the background of the use of the preparation of Sirdalud, as well as as a result of drug interaction with CYP1A2 inhibitors and / or antihypertensive drugs. A pronounced decrease in blood pressure can lead to loss of consciousness and collapse.

Interaction with other drugs

When using the drug, it is necessary to take into account interaction with other drugs:

With caution, it is necessary to take syirdalud with those drugs that extend the Qt interval (amitriptyline, cisapride, azithromycin, etc.).
It is not recommended to take a medicine with antiarrhythmic drugs (such as conpaphenon, mexylene, amiodarone), some fluoroquinolones (norfloxacin, enochasacin, perfloxicin), cimetidine, tonicidin, oral contraceptives, ropecoxib.
It is contraindicated to the use of sirdalud together with fluvoxamine, ciprofloxacin. The result of simultaneous use can be a significant decrease in blood pressure, which is accompanied by dizziness and drowsiness, in some cases - loss of consciousness.
The use of sirdalurd together with rifampicin reduces the content of tizaninine in plasma and, accordingly, reduces the therapeutic effect of the use of the drug.
Simultaneous consumption of drugs with cytochrome CYP1A2 inhibitors leads to an increase in the level of tizanidine in a plasma, which in turn leads to the appearance of symptoms of overdose. The simultaneous consumption of Sirdalud with CYP1A2 inductors leads to a decrease in the level of tizanidine, which causes a decrease in therapeutic properties of the drug.
Treatment of smoking men may require an increase in dose. Alcohol should be avoided, since the medication can increase the negative effect of alcohol on the central nervous system. Sirdalud's sedatic effect can enhance sleeping pills, sedative and antihistamines.